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Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM

NCT07690436

Not Yet RecruitingN/A

Sponsor: AstraZeneca

Conditions: Transthyretin Amyloid Cardiomyopathy

Countries: United States, Germany, Portugal, Spain

This multicenter pilot study will enroll adult participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure (HF) controls with documentation within the past 2 years that either excludes ATTR-CM or indicates a low probability of ATTR-CM. Ocular imaging and other study data will be collected to assess the feasibility of developing and preliminarily evaluating a machine learning model to discriminate ATTR-CM cases from HF controls without ATTR-CM.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 1\. Participant must be 18 years and older at the time of signing the informed consent form.
* 2\. Participants with either of the following:
* \- Positive ATTR-CM cases: Participants with a clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) with amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining, or DPD-Tc, PYP-Tc, or HMDP-Tc scintigraphy with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio.
* \- Control population: Participants with a clinical diagnosis of guideline-directed medical therapy-directed heart failure (HF) and either:
* a) Subgroup A: Definitively excluded ATTR-CM amyloidosis: negative cardiac or non-cardiac tissue biopsy for amyloid, or negative technetium scintigraphy within the past 2 years.
* b) Subgroup B: Low probability of ATTR-CM amyloidosis, not definitively excluded: absence of amyloid-suggestive features on echocardiography (ECHO), electrocardiography (ECG), or cardiac magnetic resonance imaging (MRI) within the past 2 years, with documented clinical assessment indicating HF etiology unlikely attributable to amyloidosis; no amyloid-specific testing (technetium scintigraphy or biopsy) performed.
* 3\. Participant or legally authorized representative (LAR) must sign the informed consent form.

Exclusion Criteria:

* 1\. Any known eye condition that may preclude clear imaging of the retina.
* 2\. Any known history of amyloid light-chain (AL) amyloidosis.
* 3\. Any ocular surgery that, in the opinion of the investigator, makes participation in the study undesirable.
* 4\. Any medical condition that, in the opinion of the investigator, makes participation in the study undesirable, for example, if the participant is critically unwell or requires ongoing emergency treatment.
* 5\. Involvement in the planning and/or conduct of the study.
* 6\. In the opinion of the investigator, the participant is unlikely to comply with study procedures, restrictions, and requirements.
* 7\. Previous enrollment in the present study.
Locations (10)
  • Palo Alto, California, United States
  • Chicago, Illinois, United States
  • Boston, Massachusetts, United States
  • Portland, Oregon, United States
  • Germantown, Tennessee, United States
  • Essen, Germany
  • Würzburg, Germany
  • Guimarães, Portugal
  • L'Hospitalet de Llobregat, Spain
  • Palma de Mallorca, Spain